Jcmed Tianjin Import AND Export Co., Ltd.
Registered establishment in Tianjin, China. 51 device types.
Jcmed Tianjin Import AND Export Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Enema Kit, Mask, Oxygen and 49 other device types. Its earliest product listing with the FDA dates from 2021.
Registration
| Registered name | JCMED TIANJIN IMPORT AND EXPORT CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3015821396 |
| FEI number | 3015821396 |
| Establishment type | Manufacturer, Exporter |
Location
| City | Tianjin |
|---|---|
| Province | Tianjin |
| Address | 418-419 Room, Yuanhang Business Center, Lucia Commercial Street |
| Postal code | 300300 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessory, Surgical Apparel | Class 1 | Surgical drape | 2025 | 439 |
| Airway, Oropharyngeal, Anesthesiology | Class 1 | Oropharyngeal Airway | 2025 | 84 |
| Bag, Urine Collecting, Ureterostomy | Class 1 | Ostomy bags | 2025 | 27 |
| Bag, Urine Collection, Leg, For External Use, Non-Sterile | Class 1 | Disposable Use of Drainage Bag, Non-Sterile Urine Collection Bag, leg bag (urine), Leg Bags And Accessories,, Catheter Valve, Extension Tube | 2023 | 47 |
| Balloon, Epistaxis | Class 1 | Nasal Dressing | 2025 | 6 |
| Bandage, Elastic | Class 1 | Self-Adhesive Bandage; Elastic Adhesive Bandage; Tubular Bandage; EAB Bandage; Net Bandage, Cold Bandage; Elastic Bandage; Cohesive Bandage; Conforming Bandage; Pet Bandage; Horse Bandage;, First Aid Bandage; Latex Free Bandage; Latex Free Elastic Bandage; Medical Elastic Bandage; PBT Bandage; | 2021 | 280 |
| Bandage, Liquid, Skin Protectant | Class 1 | No sting barrier film spray, BANDAGE, LIQUID, SKIN PROTECTANT | 2025 | 41 |
| Brush, Scrub, Operating-Room | Class 1 | Surgical brush | 2025 | 42 |
| Cannula, Injection | Class 1 | Cannula | 2025 | 12 |
| Cannula, Nasal, Oxygen | Class 1 | Nasal oxygen | 2025 | 97 |
| Clip, Removable (Skin) | Class 1 | Wound Closure Device | 2021 | 15 |
| Collector, Urine, (And Accessories) For Indwelling Catheter | Class 2 | Urine Drainage Bag, Urine Collector, Urine Bag, Plastic Parts, Urine Bag And Accessories, Catheter Valve, Extension Tube | 2023 | 51 |
| Container, Sharps | Class 2 | Sharp Container | 2021 | 18 |
| Container, Specimen, Sterile | Class 1 | Saliva Collection | 2025 | 79 |
| Device, Fixation, Tracheal Tube | Class 1 | Endotracheal Tube, Catheter Fixation Kit | 2025 | 46 |
| Device, Intravascular Catheter Securement | Class 1 | I.V. Catheter Dressing | 2025 | 33 |
| Dilator, Catheter | Class 1 | Chest Drainage Catheter | 2025 | 7 |
| Disinfectant, Medical Devices | Class 1 | BZK Antiseptic Swab/Antiseptic Cleaning Wipes-Sting Free | 2025 | 197 |
| Dressing, Wound, Drug | Class U | Silver Carbon dressing, Alginate with Silver Dressing | 2023 | 48 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | Class 1 | Amorphous Hydrogel Dressing; Burn Dressing; Hydrogel Gauze; Hydrogel Medical Dressing | 2022 | 118 |
| Dressing, Wound, Hydrophilic | Class 1 | Alginate dressing, Foam Dressing Set, Hydrophilic Dressing, Wound Plaster, Non Woven Dressing, Foam Dressing, Acne Patc | 2023 | 195 |
| Dressing, Wound, Occlusive | Class 1 | Nonwoven Wound Dressing; Super Absorbency Dressing; Silicone Wound Contact Dressing; Silicone Dressing Scarcin Pad;, Foam Dressing; Honey Gauze Dressing; Oil Emulsion Dressing; Petrolatum Dressing; Silicone Foam Dressing;, Hydrocolloid Dressing; Hydrocolloid Foam Dressing; Silicone Dressing; NPWT Dressing, Silicone Gel Scar Dressing; Silicone Gel Sheet; Gelling Fiber Dressing; Chest Seal; Transparent Dressing; | 2022 | 183 |
| Elastomer, Silicone, For Scar Management | Class 1 | Silicone Scar Sheet | 2025 | 85 |
| Enema Kit | Class 1 | Enema bag, Enema ball | 2025 | 24 |
| Enzyme Immunoassay, Phencyclidine | Class U | Multi-Drug Urine Test Cup; Multi-Drug Urine Test Cup Rx | 2022 | 16 |
| Exerciser, Non-Measuring | Class 1 | Breathing Exerciser; Lung Trainer; One Ball Spirometer; Respiratory Excerciser; Respiratory Meter;Three Balls Spirometer | 2025 | 82 |
| First Aid Kit With Drug | Class N | First aid kit with drug | 2023 | 57 |
| First Aid Kit Without Drug | Class 1 | First Aid Kit | 2022 | 132 |
| Gauze / Sponge,Nonresorbable For External Use | Class 1 | Gauze Bandage; Absorbent Pad; Combine Pad; Gauze Sponge; Non Adherent/Wound Dressing Pad; Foam Pad;, Adhesive Wound Dressing; Sterile Gauze Pad; ABD Pad; Non-Adherent Wound Pad; Gauze Roll; Gauze Swab;, Soluble Hemostatic Gauze; Gauze Ball | 2021 | 266 |
| Irrigator, Powered Nasal | Class 1 | Nasal irrigator | 2025 | 63 |
| Mask, Oxygen | Class 1 | Oxygen mask | 2025 | 126 |
| Mask, Oxygen, Low Concentration, Venturi | Class 1 | Venturi mask | 2025 | 46 |
| Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | Class 1 | Nebulizer kit | 2025 | 57 |
| Pack, Hot Or Cold, Reusable | Class 1 | Pack Hot or Cold Reusable | 2022 | 178 |
| Pad, Alcohol, Device Disinfectant | Class U | Alcohol Prep Pad | 2025 | 49 |
| Protector, Ostomy | Class 1 | Skin protector paster, Hydrocolloid skin barrier, Skin protective power, Anti-leakage strip,, Hydrocolloid skin protective ring | 2025 | 33 |
| Radiographic Protective Glove | Class 1 | Radiographic protective glove – Gloves | 2025 | 30 |
| Syringe, Ent | Class 1 | Ear wash ball | 2025 | 24 |
| Tape And Bandage, Adhesive | Class 1 | Medical Tape; Kinesio Tape; Kinesiology Tape; Muscle Tape; Sports Tape; Elastic Tape, PE Tape; Non-woven Tape; Silk Tape; Spunlaced Non-woven Tape; Fixing Tape; Zinc-oxide Tape; Tapes; Adhesive Tape;, Cotton Tape; Silicone Tape; Foam Tape; PU tape; Muscle Tape; Adhesive Bandage; Skin Closure Strips; Surgical Tape; | 2021 | 353 |
| Test, Amphetamine, Over The Counter | Class 2 | Multi-Drug Urine Test Cup; Multi-Drug Urine Test Cup Rx | 2022 | 16 |
| Test, Barbiturate, Over The Counter | Class 2 | Multi-Drug Urine Test Cup; Multi-Drug Urine Test Cup Rx | 2022 | 16 |
| Test, Benzodiazepine, Over The Counter | Class 2 | Multi-Drug Urine Test Cup; Multi-Drug Urine Test Cup Rx | 2022 | 16 |
| Test, Cannabinoid, Over The Counter | Class 2 | Multi-Drug Urine Test Cup; Multi-Drug Urine Test Cup Rx | 2022 | 16 |
| Test, Cocaine And Cocaine Metabolites, Over The Counter | Class 2 | Multi-Drug Urine Test Cup; Multi-Drug Urine Test Cup Rx | 2022 | 16 |
| Test, Methadone, Over The Counter | Class 2 | Multi-Drug Urine Test Cup; Multi-Drug Urine Test Cup Rx | 2022 | 17 |
| Test, Methamphetamine, Over The Counter | Class 2 | Multi-Drug Urine Test Cup; Multi-Drug Urine Test Cup Rx | 2022 | 16 |
| Test, Opiates, Over The Counter | Class 2 | Multi-Drug Urine Test Cup; Multi-Drug Urine Test Cup Rx | 2022 | 18 |
| Test, Propoxyphene, Over The Counter | Class 2 | Multi-Drug Urine Test Cup; Multi-Drug Urine Test Cup Rx | 2022 | 16 |
| Test, Tricyclic Antidepressants, Over The Counter | Class 2 | Multi-Drug Urine Test Cup; Multi-Drug Urine Test Cup Rx | 2022 | 16 |
| Tourniquet, Nonpneumatic | Class 1 | Tourniquet | 2024 | 124 |
| Wound Dressing Kit | Class 2 | Wound Dressing Kit | 2025 | 12 |
Clearances
No clearance names Jcmed Tianjin Import AND Export Co., Ltd. as applicant. 4 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K220685 | 2022-05-05 | NFT | Traditional | Qingdao Hightop Biotech Co., Ltd. |
| K192478 | 2020-06-17 | FRO | Traditional | Zhejiang Longterm Medical Technology Co., Ltd. |
| K140147 | 2014-04-22 | FRO | Traditional | Bio-Medical Carbon Technology Co., Ltd. |
| K101567 | 2010-09-02 | MMK | Traditional | Cixi Leinuo Plastic Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2000 |
|---|---|
| Main products | Medical dressings, In-vitro diagnostic reagents, Infusion products, Respiratory products, Animal medical products |
| Certifications | FDA, CE, ISO13485 |
| Export markets | 70+ countries including USA, Italy, Brazil, Philippines, Australia, Germany, Korea |
| OEM and ODM | Offered |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.